(AGENPARL) – Mon 30 June 2025 Lund, Sweden, June 30, 2025. Hansa Biopharma AB, “Hansa” (Nasdaq Stockholm:
HNSA), announced today the presentation of its five year extended pooled
analysis including data from the 17-HMedIdeS-14 study, an international long
-term follow-up study of patients who have received a kidney transplant
following desensitization with imlifidase, at the 2025 International Transplant
Congress of the European Society for Organ Transplantation (ESOT), taking place
in London, June 29 – July 2.
Massimo Mangiola, PhD, NYU Langone Transplant Institute, will present the
outcomes of the extended pooled analysis including data from the 17-HMedIdeS-14
study, presented at the American Transplant Congress (ATC) 2024, and published
as a letter to the editor in the American Journal of Transplantation.[1]
The extended pooled analysis, including data from the 17-HMedIdeS-14 study,
showed sustained positive outcomes out to five years of highly sensitized
patients who received an imlifidase-enabled kidney transplant. After five years,
the patient survival rate was 90% (reflecting three deaths occurring between six
months and one year) and graft survival (death censored) was 82%, in line with
outcomes seen at three-years.[2] At five years, mean estimated glomerular
filtration rate (eGFR) or kidney function was 50 mL/min/m[2] in the imlifidase
treated patients.
eGFR is a measure of how well the kidneys are working in the body – higher eGFR
indicates better kidney function.[3] For many kidney transplant recipients three
years post-transplant the mean eGFR is anywhere between 40-60 ml/min per 1.73
m[2] with continued decline of eGFR function at five years post-transplant.[4]
Hitto Kaufmann, Chief R&D Officer, Hansa Biopharma said, “We are very pleased to
see that the 17-HMedIdeS-14 extended pooled analysis data continue to excite the
clinical community. This study demonstrated for the first time that HLA
-incompatible transplantation following desensitization with imlifidase is a
viable option for patients who need it, with long term benefit comparable to
standard kidney transplants, providing a life changing alternative to remaining
on dialysis.”
Speaker Abstract Title Presentation Details
Massimo “Five years follow Monday 30 June, 11:10 – 11:20 BST. Part of the
Mangiola, up of imlifidase FOS_04 session: Innovation in solid organ
PhD desensitized transplantation
kidney transplant
recipients (https:/
/esot-apps.m
-anage.com/esot2025
/en
-GB/pag/presentatio
n/537965)” – Oral
presentation
17-HMedIdeS-14 is part of the HMedIdeS clinical program for imlifidase. The
program includes four global phase 2 trials (13-HMedIdeS-02, 13-HMedIdeS-03, 14
-HMedIdeS-04 and 15-HMedIdeS-06), one US open-label phase 3 trial (ConfIdeS), a
long-term follow up study (17-HMedIdeS-14) and a post-authorization efficacy and
safety study in Europe (PAES).
The 17-HMedIdeS-14 study included patients who consented to long-term follow-up
and had previously received an imlifidase-enabled transplant in Hansa’s phase 2
studies. The 5-year extended pooled analysis is a continuation of the analysis
at 3-years of crossmatch positive only patients published in the American
Journal of Transplantation.[1]
— ENDS —
Contacts for more information:
Evan Ballantyne, Chief Financial Officer
Stephanie Kenney, VP Global Corporate Affairs
Notes to editors
About highly sensitized patients
Highly sensitized patients have pre-formed antibodies called donor specific
antibodies (DSAs) with a broad reactivity against human leukocyte antigens
(HLAs), which can cause tissue damage and potentially transplant rejection.[5]
The presence of DSAs means that highly sensitized patients tend to have limited
or no access to transplant, as finding a compatible donor organ can be
particularly challenging.[6.7] The complexity of their immunological profile
means that highly sensitized patients spend longer time than average on
transplant waiting lists, with evidence showing that this longer time waiting
for a suitable donor relates to an increased mortality risk.[8,9] Across the
U.S. and Europe, highly sensitized patients comprise around 10-15% of the total
of patients on transplant waiting lists.[10,11]
About IDEFIRIX[®] (imlifidase)
Imlifidase is an antibody-cleaving enzyme originating from Streptococcus
pyogenes that specifically targets and cleaves immunoglobulin G (IgG) antibodies
and inhibits IgG-mediated immune response.[12] It has a rapid onset of action,
cleaving IgG-antibodies and inhibiting their activity within hours after
administration.
Imlifidase has conditional marketing approval in Europe and is marketed under
the trade name IDEFIRIX for the desensitization treatment of highly sensitized
adult kidney transplant patients with a positive crossmatch against an available
deceased donor. The use of IDEFIRIX should be reserved for patients who are
unlikely to be transplanted under the available kidney allocation system,
including prioritization programs for highly sensitized
patients.[12] IDEFIRIX was reviewed as part of the European Medicines Agency’s
(EMA) PRIority Medicines (PRIME) program, which supports medicines that may
offer a major therapeutic advantage over existing treatments or benefit patients
without treatment options.[12]
Imlifidase is a promising new strategy for desensitization of transplant
patients with donor-specific anti-HLA (Human Leukocyte Antigens) antibodies
(DSAs).[13] Highly sensitized patients have high levels of these preformed
antibodies that can bind to the donor organ and damage the transplant.[5] Once
they are inactivated with imlifidase, there is a window of opportunity for the
transplant to take place. By the time the body starts to synthesize new IgG, the
patient will be receiving post-transplant immunosuppressive therapy to reduce
the risk of organ rejection.
The efficacy and safety of imlifidase as a pre-transplant treatment to reduce
donor-specific IgG was studied in four phase 2 open-label, single-arm, six
-month clinical trials.[11,13-15 ]Hansa is collecting further clinical evidence
and will submit additional efficacy and safety data based on one observational
follow-up study and one post-approval efficacy study.
Full product information can be accessed via the initial Summary of Product
Characteristics found here (https://www.ema.europa.eu/en/documents/product
-information/idefirix-epar-product-information_en.pdf).
About kidney failure
Kidney disease can progress to kidney failure or End-Stage Renal Disease (ESRD),
identified when a patient’s kidney function is less than 15%.[16] ESRD poses a
significant health burden, affecting nearly 2.5 million patients
worldwide.[16] A kidney transplant is the treatment of choice for suitable
patients with ESRD because it offers improved survival and quality of life
benefits, and is cost savings compared to long-term dialysis. There are
approximately 170,000 kidney patients in the U.S. and Europe waiting for a new
kidney.[17]
About Hansa Biopharma
Hansa Biopharma AB is a pioneering commercial-stage biopharmaceutical company on
a mission to develop and commercialize innovative, lifesaving and life-altering
treatments for patients with rare immunological conditions. The company has a
rich and expanding research and development program based on its proprietary IgG
-cleaving enzyme technology platform, to address serious unmet medical needs in
autoimmune diseases, gene therapy and transplantation. The company’s portfolio
includes imlifidase, a first-in-class immunoglobulin G (IgG) antibody-cleaving
enzyme therapy, which has been shown to enable kidney transplantation in highly
sensitized patients and HNSA-5487, a next-generation IgG cleaving molecule with
redosing potential. Hansa Biopharma is based in Lund, Sweden, and has operations
in Europe and the U.S. The company is listed on Nasdaq Stockholm under the
ticker HNSA. Find out more at http://www.hansabiopharma.com and follow us on
LinkedIn (https://www.linkedin.com/company/hansa-medical-ab/).
©2025 Hansa Biopharma AB. Hansa Biopharma, the beacon logo, IDEFIRIX, and
IDEFIRIX flower logo are trademarks of Hansa Biopharma AB, Lund, Sweden. All
rights reserved.
References
1. Jordan SC, et al. Long-term outcomes at 5 years posttransplant in imlifidase
-desensitized kidney transplant patients. Am J Transplant. 2025 Apr;25(4):878
2. Kjellman C, et al. Outcomes at 3 years posttransplant in imlifidase
-desensitized kidney transplant patients. Am J Transplant. 2021 Dec;21(12):3907
3. American Kidney Fund. Blood test: eGFR (estimated glomerular filtration
rate). Available at: https://www.kidneyfund.org/all-about-kidneys/tests/blood
-test-egfr. Accessed May 2025 (https://www.kidneyfund.org/all-about
-kidneys/tests/blood-test-egfr.%20Accessed%20May%202025).
4. Huang Y, Tilea A, Gillespie B, Shahinian V, Banerjee T, Grubbs V, Powe N,
Rios-Burrows N, Pavkov M, Saran R. Understanding Trends in Kidney Function 1
Year after Kidney Transplant in the United States. J Am Soc Nephrol. 2017
5. Eurostam Report (A Europe-wide strategy to enhance transplantation of highly
sensitized patients on the basis of acceptable HLA mismatches.) Available
at https://cordis.europa.eu/project/id/305385/reporting.
6. Redfield RR, et al. The mode of sensitization and its influence on allograft
outcomes in highly sensitized kidney transplant recipients. Nephrol Dial
Transplant. 2016 Oct;31(10):1746-53. doi: 10.1093/ndt/gfw099.
7. Lonze BE, et al. IdeS (Imlifidase): A Novel Agent That Cleaves Human IgG and
Permits Successful Kidney Transplantation Across High-strength Donor-specific
Antibody. Ann Surg. 2018 Sep;268(3):488-496. doi: 10.1097/
8. Alelign T, Ahmed MM, Bobosha K, Tadesse Y, Howe R, Petros B. Kidney
Transplantation: The Challenge of Human Leukocyte Antigen and Its Therapeutic
9. Heidt S, et al. Highly Sensitized Patients are Well Serves by Recieving a
Compatible Organ Offer Based on Acceptable Mismatches. Front Immunol.
10. Organ Procurement and Transplantation Network (OPTN) and Scientific Registry
of Transplant Recipients (SRTR). OPTN/SRTR 2022 Annual Data Report. U.S.
Department of Health and Human Services, Health Resources and Services
Administration; 2024. Accessed May 2024.
11. Jordan SC, et al. Imlifidase Desensitization in Crossmatch-positive, Highly
Sensitized Kidney Transplant Recipients: Results of an International Phase 2
Trial (Highdes). Transplantation. 2021 Aug 1;105(8):1808-1817. doi:
12. European Medicines Agency. Idefirix[®] summary of product characteristics.
Available at: https://www.ema.europa.eu/en/documents/product
-information/idefirix-epar-product-information_en.pdf.
13. Jordan SC, et al. IgG Endopeptidase in Highly Sensitized Patients Undergoing
Transplantation. N Engl J Med  2017;377:442-453. DOI: 10.1056/NEJMoa16125
14. Winstedt L, et al. Complete Removal of Extracellular IgG Antibodies in a
Randomized Dose-Escalation Phase I Study with the Bacterial Enzyme IdeS–A Novel
15. Lorant T, et al. Safety, immunogenicity, pharmacokinetics, and efficacy of
degradation of anti-HLA antibodies by IdeS (imlifidase) in chronic kidney
disease patients. Am J Transplant. 2018 Nov;18(11):2752-2762. doi:
10.1111/ajt.14733.
16. NIH (2018). What is kidney failure? Available at:
https://www.niddk.nih.gov/health-information/kidney-disease/kidney-failure/what
-is-kidney-failure.
17. Newsletter Transplant 2022. International figures on donation and
transplantation. Available at: Newsletter Transplant – latest edition I Freepub
(edgm.eu) Accessed: May 2025
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